BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE INFUSION PUMP

    MDR report key: 6072609 · Received November 2, 2016

    Report

    Report Number
    3007566237-2016-03862
    Event Type
    Injury
    Date Received
    November 2, 2016
    Date of Event
    August 16, 2016
    Report Date
    November 2, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENT. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_PUMP LOT# UNKNOWN SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE PUMP. PRODUCT ID NEU_UNKNOWN_CATH, PRODUCT TYPE: CATHETER. PRODUCT ID NEU_UNKNOWN_PUMP, PRODUCT TYPE: PUMP. PRODUCT ID NEU_UNKNOWN_PUMP, PRODUCT TYPE: PUMP. PRODUCT ID NEU_UNKNOWN_PUMP, PRODUCT TYPE: PUMP. PRODUCT ID NEU_UNKNOWN_PUMP, PRODUCT TYPE: PUMP. PRODUCT ID NEU_UNKNOWN_PUMP, PRODUCT TYPE: PUMP. PRODUCT ID NEU_UNKNOWN_PUMP, PRODUCT TYPE: PUMP. PRODUCT ID NEU_UNKNOWN_PUMP, PRODUCT TYPE: PUMP. PRODUCT ID NEU_UNKNOWN_PUMP, PRODUCT TYPE: PUMP. PRODUCT ID NEU_UNKNOWN_PUMP, PRODUCT TYPE: PUMP. PRODUCT ID NEU_UNKNOWN_PUMP, PRODUCT TYPE: PUMP. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DHIR, M., ZENATI, M.S., PADUSSIS, J.C., JONES, H.L., PERKINS, S., CLIFFORD, A.K., STEVE, J., HOGG, M.E., CHOUDRY, H.A., HOLTZMAN, M.P., ZEH, H.J., PINGPANK, J.F., BARTLETT, D.L., ZUREIKAT, A.H. ROBOTIC ASSISTED PLACEMENT OF HEPATIC ARTERY INFUSION PUMP IS A SAFE AND FEASIBLE APPROACH. JOURNAL OF SURGICAL ONCOLOGY. 2016;114(3):342-347. DOI 10.1002/JSO.24325. SUMMARY: HEPATIC ARTERY INFUSION (HAI) CHEMOTHERAPY CAN BE COMBINED WITH SYSTEMIC CHEMOTHERAPY FOR THE TREATMENT OF ISOLATED UNRESECTABLE COLORECTAL LIVER METASTASES (IU-CRLM) AND INTRAHEPATIC CHOLANGIOCARCINOMA (U-ICC). HOWEVER, HAI PUMP PLACEMENT REQUIRES A MAJOR LAPAROTOMY THAT MAY BE ASSOCIATED WITH MORBIDITY. WE HYPOTHESIZED THAT THE COMPUTER-ASSISTED ROBOTIC PLATFORM WOULD BE WELL SUITED FOR THIS PROCEDURE AND REPORT THE FIRST SINGLE INSTITUTIONAL CASE SERIES OF ROBOTIC ASSISTED HAI PUMP PLACEMENT FOR PRIMARY AND SECONDARY MALIGNANCIES OF THE LIVER. REPORTED EVENTS: ONE PATIENT EXPERIENCED A PUMP POCKET HEMATOMA WHICH WAS EVACUATED IN THE OPERATING ROOM; ONE PATIENT DEVELOPED A CHA DISSECTION DURING ATTEMPTED EMBOLIZATION OF ACCESSORY DUODENAL BRANCHES OFF OF THE PROXIMAL CHA. ALTHOUGH THE PATIENT DID NOT SUFFER ANY LONG-TERM SEQUELAE FROM THE COMPLICATION, THE PUMP WAS NEVER ACCESSED, REPRESENTING THE ONLY CASE IN WHICH HAI PUMP WAS NOT UTILIZED DUE TO TECHNICAL REASONS. THE PATIENT HAD CATHETER MIGRATION AS WELL; ONE PATIENT PRESENTED TWO WEEKS AFTER PUMP PLACEMENT WITH ACUTE ONSET HEADACHES AND BLURRED VISION AND WAS FOUND TO HAVE BILATERAL OCCIPITAL HEMORRHAGES. THIS PATIENT SUBSEQUENTLY BECAME UNRESPONSIVE, COMFORT MEASURES WERE PURSUED PER FAMILY AND THE PATIENT SUBSEQUENTLY PASSED AWAY. NO DEFINITIVE DIAGNOSIS WAS CONFIRMED BUT DIFFERENTIAL DIAGNOSES INCLUDED HEMORRHAGIC POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME (PRES), METASTASES OR VENOUS INFARCTS; NOTABLE THIS COMPLICATION SEEMED UNRELATED TO THE PUMP PLACEMENT; ONE PATIENT EXPERIENCED A PERIOPERATIVE COMPLICATION OF ILEUS; ONE PATIENT EXPERIENCED A PERIOPERATIVE COMPLICATION OF SUPRAVENTRICULAR TACHYCARDIA (SVT); ONE PATIENT EXPERIENCED A PERIOPERATIVE COMPLICATION OF ANEMIA REQUIRING TRANSFUSION; ONE PATIENT EXPERIENCED A PERIOPERATIVE COMPLICATION OF URINARY RETENTION; ONE PATIENT EXPERIENCED A PERIOPERATIVE COMPLICATION OF A GENERALIZED RASH REQUIRING STEROIDS; ONE PATIENT EXPERIENCED A PERIOPERATIVE COMPLICATION OF DEHYDRATION; ONE PATIENT EXPERIENCED A PUMP-RELATED COMPLICATION OF A DUODENAL ULCER. THE PUMP STUDY RULED OUT EXTRAHEPATIC PERFUSION AND THE ULCER WAS MEDICALLY MANAGED; ONE PATIENT EXPERIENCED A PUMP-RELATED COMPLICATION OF AN INFECTION. THE PUMP WAS REMOVED BUT THE PATIENT HAD ALREADY COMPLETED THERAPY AND WAS OVER 1 YEAR OUT; ONE PATIENT EXPERIENCED A PUMP-RELATED COMPLICATION OF BILIARY SCLEROSIS REQUIRING STENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723852 IMPLANTABLE INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention